BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DJO SURGICAL

    DI: 00190446226703 · Model: 804-07-208 · Encore Medical, L.P.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DJO SURGICAL
    Primary DI
    00190446226703
    Version / Model
    804-07-208
    Company Name
    Encore Medical, L.P.
    Labeler DUNS
    154074504
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-03-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    d12d2f2e-e613-4077-8f83-187c97fc8684

    Device Description

    AltiVate Anatomic, Humeral Broach, 8mm

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    KWS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
    HSD PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
    PAO prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

    GMDN Terms

    Code Name
    36167 Orthopaedic broach

    Identifiers

    Type ID
    Primary 00190446226703

    Premarket Submissions

    Submission Number Supplement Number
    K162024 000